Observational Study
Copyright ©The Author(s) 2022. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastroenterol. Sep 14, 2022; 28(34): 5058-5075
Published online Sep 14, 2022. doi: 10.3748/wjg.v28.i34.5058
Impact of adalimumab on disease burden in moderate-to-severe ulcerative colitis patients: The one-year, real-world UCanADA study
Talat Bessissow, Geoffrey C Nguyen, Osman Tarabain, Laurent Peyrin-Biroulet, Nathalie Foucault, Kevin McHugh, Joannie Ruel
Talat Bessissow, Department of Medicine, McGill University Health Center, Montreal H3G 1A4, Quebec, Canada
Geoffrey C Nguyen, Mount Sinai Hospital Inflammatory Bowel Disease Centre, Toronto M5T 3L9, Ontario, Canada
Osman Tarabain, Dr. O. Tarabain Clinic, Windsor N8W 1E6, Ontario, Canada
Laurent Peyrin-Biroulet, Department of Gastroenterology, University of Lorraine, CHRU-Nancy, Nancy F-54000, France
Nathalie Foucault, Kevin McHugh, AbbVie Corporation, Saint-Laurent H4S 1Z1, Quebec, Canada
Joannie Ruel, Department of Medicine, Sherbrooke University Hospital Center, Sherbrooke J1H 5N4, Quebec, Canada
Author contributions: Bessissow T was involved in study design, coordinating the data collection, interpretation of the results, and review and revision of the manuscript; Ruel J, Nguyen GC, and Tarabain O were involved in coordinating the data collection, interpretation of the results, and review and revision of the manuscript; Foucault N and McHugh K were involved in study design, interpretation of the results, and review and revision of the manuscript.
Institutional review board statement: All sites had the study reviewed and approved by an ethics committee. While CEC Advarra IRB Services (Aurora, Ontario, Canada) reviewed and approved for some sites, other sites were approved through local/multi centres ethics committees (Dr. Everett Chalmers Regional Hospital, MUHC-Royal Victoria Hospital, CHUM-Hôpital Maisonneuve-Rosemont, CHAU-Hôpital Hôtel-Dieu de Levis, Royal University Hospital, Centre Hospitalier de l'Université de Sherbrooke, CHUM-Hôpital St-Luc, Zeidler Ledcor Centre, Ottawa Hospital-General Campus, Mount Sinai Hospital, London Health Sciences Centre, Centre Hospitalier de l'Université Laval (CHUL), University of Calgary Gastrointestinal Research Group).
Informed consent statement: All patients were required to sign a patient authorization form (or written informed consent) to participate in the study, and to disclose personal health information.
Conflict-of-interest statement: The authors have either received research support from, served as consultant, speakers bureau, scientific officer, participants of steering committees and advisory boards, and/or received honoraria from the following sponsors: T.B.: AbbVie, Janssen, Takeda, Merck, Pfizer, Roche, Bristol Myers Squibb, Gilead, Sandoz, Ferring, Alimentiv Inc. (formerly Robarts Clinical Trials); J.R.: AbbVie, Janssen, Takeda, Pfizer, Sandoz, Ferring, Alimentiv Inc. (formerly Robarts Clinical Trials); G.N.: AbbVie and Takeda; O.T.: AbbVie; N.F. and K.M.: are employees of AbbVie and may own AbbVie stock; L.P.B.: Dr. Peyrin-Biroulet reports personal fees from Galapagos, AbbVie, Janssen, Genentech, Ferring, Tillots, Celltrion, Takeda, Pfizer, Index Pharmaceuticals, Sandoz, Celgene, Biogen, Samsung Bioepis, Inotrem, Allergan, MSD, Roche, Arena, Gilead, Amgen, BMS, Vifor, Norgine, Mylan, Lilly, Fresenius Kabi, OSE Immunotherapeutics, Enthera, Theravance, Pandion Therapeutics, Gossamer Bio, Viatris, Thermo Fisher. Grants from AbbVie, MSD, Takeda, Fresenius Kabi. Stock options: CTMA.
Data sharing statement: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and Clinical Study Reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications. This clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). Data requests can be submitted at any time and the data will be accessible for 12 mo, with possible extensions considered. For more information on the process, or to submit a request, visit the following link: https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html.
STROBE statement: The authors have read the STROBE Statement—checklist of items, and the manuscript was prepared and revised according to the STROBE Statement—checklist of items.
Open-Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: https://creativecommons.org/Licenses/by-nc/4.0/
Corresponding author: Talat Bessissow, FRCP (C), MD, MSc, Associate Professor, Department of Medicine, McGill University Health Center, 1650 Avenue Cedar, Montreal H3G 1A4, Quebec, Canada. talat.bessissow@mcgill.ca
Received: March 30, 2022
Peer-review started: March 30, 2022
First decision: June 10, 2022
Revised: July 27, 2022
Accepted: August 17, 2022
Article in press: August 17, 2022
Published online: September 14, 2022

A gap remains in documenting the impact of anti-tumor necrosis factor therapy on disease burden in ulcerative colitis (UC) patients treated in a real-world setting. The use of patient-reported outcomes (PROs) has been discussed as a primary endpoint in the context of the FDA PRO Guidance, for labelling purposes. Specifically, the efficacy and safety of adalimumab have been demonstrated in pivotal trials; however, data are needed to understand how clinical results translate into improvements in key aspects of the daily lives of UC patients, such as symptoms, health-related quality of life (HRQoL), and disability.


To assess real-world effectiveness of adalimumab on PRO measures in patients with moderate-to-severe UC.


UCanADA was a single arm, prospective, 1-year multicenter Canadian post-marketing observational study in which multiple PRO questionnaires were completed—with psychologic distress/depression symptoms as the primary endpoint—by patients with moderate-to-severe UC. Assessments were performed during patients’ routine care visit schedule, which was at the initiation of adalimumab (baseline), after induction (approximately 8 wk), and 52 wk after baseline. Additional optional assessments between weeks 8 and 52 were collected at least once but no more than two times during this period. Serious safety events and per-protocol adverse events were collected.


From 23 Canadian centres, 100 patients were enrolled and 48 completed the study. Measured with the Patient Health Questionnaire–9 items at week 52, 61.5% (40/65) [95% confidence interval (CI): 49.7%-73.4%] of the patients improved in psychologic distress/depression symptoms, which was slightly higher in completers [65.9% (29/44); 95%CI: 51.9%-79.9%)]. At week 52, clinical response and clinical remission were achieved respectively by 65.7% (44/73) and 47.8% (32/73) of the patients. The odds of improving depressive symptoms for those achieving a clinical remission at week 52 was 7.94 higher compared with those not achieving a clinical remission (CI: 1.42, 44.41; P = 0.018). Significant changes from baseline to weeks 8 and 52 were observed in disability, HRQoL, and fatigue. Meaningful improvement was reported in work impairment.


At week 52, over 60% of the UCanADA patients had depressive symptoms significantly reduced, as well as HRQoL, fatigue symptoms, and work impairment improved. No new safety signals were detected.

Keywords: Disease burden, Patient-reported outcome, Depressive symptoms, Ulcerative colitis, Adalimumab, Real-world data

Core Tip: In real-world at week 52, over 60% of patients with moderate-to-severe ulcerative colitis treated with adalimumab had their depressive symptoms improved, as well as their quality of life, fatigue symptoms, and work impairment. No new safety signals were detected.